MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PLATINUM PLUS; WIRE, GUIDE, CATHETER

Model Number	40295
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that distal tip detachment occurred requiring additional intervention.A 018/260 platinum plus guidewire was used during the procedure.However, it was observed that the wire and an axillary balloon pump were separated inside the patient's body.The physician had to gain femoral access and snared the distal portion of the wire.The device was removed and the procedure was completed with no patient complications nor injuries reported.
Event or Problem Description
It was reported that distal tip detachment occurred requiring additional intervention.A 018/260 platinum plus guidewire was used during the procedure.However, it was observed that the wire and an axillary balloon pump were separated inside the patient's body.The physician had to gain femoral access and snared the distal portion of the wire.The device was removed and the procedure was completed with no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with its original pouch, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The guidewire returned was inspected and it is possible to observe the core wire was detached at 255cm from proximal section.The wire returned was inspected and it is possible to observe the core wire was detached.The outer dimensions were found within specification.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.

• Brand Name: PLATINUM PLUS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15480486
• Report Number: 2124215-2022-34778
• Device Sequence Number: 14866020
• Product Code: DQX
• UDI-Device Identifier: 08714729326212
• UDI-Public: 08714729326212
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K945379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/25/2025
• Device Model Number: 40295
• Device Catalogue Number: 40295
• Device Lot Number: 0029833585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown